This white paper describes the legal frameworks adopted by the European Union and the United States and the resulting requirements for pharmaceutical companies. It provides practical tips on best practice for coding, production processes, packaging design and data infrastructure.

In addition, the white paper compares the similarities and differences between the FMD and the DSCSA in the following areas:

Tamper protection

Supply chain documentation

Three-pronged security design

Data matrix codes, product identifiers & SNI

Protection against counterfeiting

Management of serialization data

Aggregation

Download this informative white paper to learn more

Both the FMD as well the DSCSA require inspection systems with the ability to print serialized 2D codes to verify them and which can handle communication with a centralized database/ERP system. Manufacturers who make their production lines fit both the requirements of US serialization from 27 November 2017 as well as the EU's FMD requirements from 9 February 2019 will be in a position to comply with the pending 2023 DSCSA specifications.

Europe and the United States are considered the world leaders in the safest pharmaceutical markets for patients. However: With 840 million inhabitants, and two-thirds of global pharmaceutical sales, the US and Europe are also a lucrative target for drug crime. New sales channels such as the internet make it increasingly easier for pharmaceutical counterfeiters to market counterfeits directly or to infiltrate the supply chain. These new legal frameworks have been introduced to combat this global threat.

METTLER TOLEDO uses cookies on this site to improve the quality of our services and to provide you with a personalized experience. See our Cookie Policy.

Thank you for visiting www.mt.com. We have tried to optimize your experience while on the site, but we noticed that you are using an older version of a web browser. We would like to let you know that some features on the site may not be available or may not work as nicely as they would on a newer browser version. If you would like to take full advantage of the site, please update your web browser to help improve your experience while browsing www.mt.com.